BESREMi targets ET where it starts
BESREMi is the first FDA-approved treatment for adults with essential thrombocythemia (ET) in nearly 30 years.
BESREMi is not chemotherapyA treatment that uses drugs to kill cancer cells or slow their growth.. It’s an innovative immunotherapyA treatment that uses certain parts of the body’s immune system to fight disease. that works with your immune system to target ET where it starts—in the bone marrowThe soft, spongy tissue inside bones that makes blood cells.. This is where your body makes plateletsSmall cell fragments that help form clots and stop bleeding., red blood cellsA common type of blood cell that delivers oxygen to the rest of the body. (RBC), and white blood cellsA type of blood cell that helps the body fight infections and disease. Some people with ET have high WBC counts in addition to platelets. (WBC).
BESREMi was studied after HU resistance or intolerance
In a study of 174 adults, BESREMi was compared with anagrelide, a platelet-lowering treatment traditionally used for people with ET who were resistant to or could not tolerate hydroxyureaA type of chemotherapy that reduces the production of abnormal blood cells and lowers the risk of blood clots. (HU).
Who took part in the study?
Everyone in the study was HU-intolerantWhen side effects make it difficult or unsafe to continue taking HU. or HU-resistantWhen HU is not controlling ET well enough after an adequate trial of treatment. and at high risk for ET-related complications.
| Outcome | BESREMi group | anagrelide group |
|---|---|---|
| Number of people | 91 | 83 |
| Age range (median age) | 21–80 years (61) | 20–83 years (64) |
| Experienced a thrombotic eventSituations where blood clots form in a blood vessel or the heart, which can block blood flow. before the study | 38% | 31% |
People taking BESREMi were about 10x more likely to achieve ET control*
In this study, 37.4% of people taking BESREMi achieved ET control, compared with 3.6% for those taking anagrelide. ET control meant meeting all 3 measures below:
The study’s main goal was to evaluate ET control using 3 measures together. The results for each measure are shown below to provide additional information, but the study was not designed to evaluate each measure separately.
Platelet and WBC counts in the normal range
SpleenAn organ in the upper left abdomen that filters and stores blood cells. size improved or maintained
No blood clotsWhen blood platelets, proteins, and cells stick together, forming a mass that can slow or block blood flow. or major bleeding events
*In a clinical study of 174 patients, control was defined as bringing key blood counts into the normal range, maintaining or improving spleen size, and having no blood clots or major bleeding events.
†Based on results from Months 9 and 12 of the study.
FAQs about BESREMi
What makes BESREMi different?
Is BESREMi chemotherapy?
How does BESREMi work?
What does it mean to be resistant to or intolerant of hydroxyurea (HU)?
Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely. Talk to your healthcare provider if you have any questions.
What is the most important information I should know about BESREMi?
BESREMi can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking BESREMi permanently. These symptoms may go away in some people after they stop taking BESREMi.
Mental health problems, including suicide
BESREMi may cause mood or behavior problems that can get worse during treatment or after your last dose, including:
- Irritability (getting upset easily)
- Restlessness and agitation
- Confusion
- Depression (feeling low, hopeless, or bad about yourself)
- Unusually grand ideas
- Acting aggressive or impulsively
- Thoughts of hurting yourself or others, or thoughts of suicide
If you develop any of these symptoms, call your healthcare provider immediately.
New or worsening autoimmune problems
BESREMi may cause your immune system to attack healthy cells, leading to conditions such as thyroid disease, increased blood sugar (hyperglycemia), or type 1 diabetes. Call your healthcare provider if you experience:
- Extreme tiredness
- Frequent urination
- Excessive thirst
Heart problems
BESREMi may cause heart problems, including:
- Cardiomyopathy (heart muscle disease)
- Heart attack
- Irregular heartbeat (atrial fibrillation)
- Decreased blood flow to the heart
You should not take BESREMi if you have:
- Uncontrolled high blood pressure
- Congestive heart failure
- A serious abnormal heart rhythm
- Narrowing of the arteries to your heart
- Certain types of chest pain (angina)
- A recent stroke or heart attack
Who should not take BESREMi?
Do not take BESREMi if you:
- Have or had severe mental health problems, especially depression, suicidal thoughts, or attempted suicide
- Have or had a serious or untreated autoimmune disease
- Are allergic to interferon or any ingredient in BESREMi (symptoms may include itching, swelling, trouble breathing, dizziness, or chest pain)
- Have certain types of liver disease
- Have had a transplant and take immune-suppressing medication
Before using BESREMi, tell your healthcare provider about all of your medical conditions, including if you have any of the following:
- A mental illness
- Type 1 diabetes
- Heart or bleeding problems
- Problems with your immune system
- Hepatitis B or HIV infection
- Kidney or liver problems
- Are pregnant or planning to become pregnant
- –BESREMi may harm your unborn baby. Use effective birth control during treatment and for at least 8 weeks after your last dose
- –BESREMi may affect your menstrual cycle and could stop your periods
- –Do not breastfeed while taking BESREMi
What are the possible side effects of BESREMi?
Serious side effects include:
- Low blood cell counts: Taking BESREMi can lead to infections, anemia, or bleeding problems. Call your healthcare provider right away if you develop weakness and tiredness, bruising easily, nose bleeds often, fever, chills, burning and painful urination, urinating often, or coughing up yellow or pink mucus (phlegm)
- Serious allergic reactions: Get medical help right away if you get any of the following symptoms: skin rash or hives; itching; swelling of the face, eyes, lips, tongue, or throat; trouble breathing; chest pain; or feeling faint
- Eye problems: BESREMi can cause severe eye problems with your retinas that can lead to vision loss or blindness. You should have an eye exam before and during treatment with BESREMi if you have diabetes or high blood pressure and also have retinal problems
- Liver problems: BESREMi can cause increases in liver enzymes and liver damage. Your healthcare provider should do blood tests to monitor your liver enzymes and liver function before you start and during treatment with BESREMi
- Kidney problems: Your healthcare provider will do blood tests to check your kidney function before starting and during treatment with BESREMi. Tell your healthcare provider right away if you develop any symptoms of a kidney problem, including: changes in the amount or color of your urine, swelling in your ankles, blood in your urine, or loss of appetite
- Tooth and gum problems: BESREMi can cause tooth loss and/or dry mouth. It is important for you to brush your teeth well, two times each day and have regular dental examinations during treatment with BESREMi
- Skin reactions: BESREMi may cause reaction such as rash, itching, and hair loss
- Increased triglycerides: You may require blood tests to monitor levels
The most common side effects of BESREMi include increased liver function tests, low red blood cell counts (anemia), fever, increased protein in the urine, bacterial infection, itching, and weight loss.
These are not all of the possible side effects of BESREMi.
Call your doctor for medical advice about side effects. You may report side effects to PharmaEssentia at 1-800-999-2449 or FDA at 1-800-FDA-1088.
What is BESREMi used for?
BESREMi is for the treatment of adults with essential thrombocythemia.
Please see full Prescribing Information, including Boxed Warning and Medication Guide.
Read this Important Safety Information carefully. It explains the serious risks of BESREMi and how to take it safely.
Talk to your healthcare provider if you have any questions.
What is the most important information I should know about BESREMi?
BESREMi can cause serious side effects, including conditions that may cause death or may worsen certain serious diseases you may already have. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking BESREMi permanently. These symptoms may go away in some people after they stop taking BESREMi.